Isotretinoin
- Product NDC
- 68308-573
- 11-digit product format
- 683080573
- Labeler code
- 68308
- Product ID
- 68308-573_66d6a601-cb08-4662-a043-537a6f8d935b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Isotretinoin
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Mayne Pharma
- Application
- ANDA212333
- Marketing category
- ANDA
- Marketing start
- 2021-09-21
- Substance
- ISOTRETINOIN
- Active strength
- 30 mg/1
- Pharmacologic classes
- Retinoid [EPC], Retinoids [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Isotretinoin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ISOTRETINOIN | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | EH28UP18IF |
| Rxcui | 197843, 197844, 403930 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68308-573-01 | Isotretinoin | 10 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 10 | | 2 |
| 68308-573-30 | Isotretinoin | 3 in 1 BOX | CAPSULE, LIQUID FILLED | 3 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68308-573 | ISOTRETINOIN CAPSULE, LIQUID FILLED [MAYNE PHARMA] | 2 | Current NDC, Legacy NDC, 2 package rows | 20221105_ebe1b3e3-1013-4cf6-bdc8-2baa3dc26e16.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68308-573-01 | 68308057301 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 68308-573-30 | 68308057330 | 3 BLISTER PACK in 1 BOX (68308-573-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68308-573-01) | 3 blister pack | 2021-09-21 | 0000-00-00 | No | No | Current |